For Patients

Pentasa (mesalamine) is an anti-inflammatory agent used to treat ulcerative colitis, proctitis, and proctosigmoiditis. Pentasa is also used to prevent the symptoms of ulcerative colitis from recurring. Common side effects of Pentasa include diarrhea, headache, nausea, vomiting, stomach cramps, gas, fever, sore throat, other flu symptoms, constipation, dizziness, tired feeling, or skin rash.

The recommended dosage of Pentasa for the induction of remission and the symptomatic treatment of mildly to moderately active ulcerative colitis is 1g (four 250 mg capsules or two 500 mg capsules) 4 times a day for a total daily dosage of 4g. Treatment duration may be up to 8 weeks. Pazathioprine or mercaptopurine, pentamidine, tacrolimus, amphotericin B, antibiotics, antiviral medicines, cancer medicine, or aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs). Tell your doctor all medications you are taking. During pregnancy, Pentasa should be used only when prescribed. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Our Pentasa (mesalamine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

SIDE EFFECTS: Diarrhea, headache, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: change in the amount of urine, dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, chest pain, shortness of breath.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

SIDE EFFECTS

In combined domestic and foreign clinical trials, more
than 2100 patients with ulcerative colitis or Crohn's disease received PENTASA
therapy. Generally, PENTASA therapy was well tolerated. The most common events
(ie, greater than or equal to 1%) were diarrhea (3.4%), headache (2.0%), nausea
(1.8%), abdominal pain (1.7%), dyspepsia (1.6%), vomiting (1.5%), and rash
(1.0%).

In two domestic placebo-controlled trials involving over
600 ulcerative colitis patients, adverse events were fewer in PENTASA® (mesalamine)-treated
patients than in the placebo group (PENTASA 14% vs placebo 18%) and were not
dose-related. Events occurring at 1% or more are shown in the table below. Of
these, only nausea and vomiting were more frequent in the PENTASA group.
Withdrawal from therapy due to adverse events was more common on placebo than
PENTASA (7% vs 4%).

Table 1: Adverse Events Occurring in More than 1% of
Either Placebo or PENTASA Patients in Domestic Placebo-controlled Ulcerative
Colitis Trials. (PENTASA Comparison to Placebo)

Event

PENTASA
n=451

Placebo
n=173

Diarrhea

16 (3.5%)

13 (7.5%)

Headache

10 (2.2%)

6 (3.5%)

Nausea

14 (3.1%)

-----

Abdominal Pain

5 (1.1%)

7 (4.0%)

Melena (Bloody Diarrhea)

4 (0.9%)

6 (3.5%)

Rash

6 (1.3%)

2 (1.2%)

Anorexia

5 (1.1%)

2 (1.2%)

Fever

4 (0.9%)

2 (1.2%)

Rectal Urgency

1 (0.2%)

4 (2.3%)

Nausea and Vomiting

5 (1.1%)

-----

Worsening of Ulcerative Colitis

2 (0.4%)

2 (1.2%)

Acne

1 (0.2%)

2 (1.2%)

Clinical laboratory measurements showed no significant
abnormal trends for any test, including measurement of hematological, liver,
and kidney function.

The following adverse events, presented by body system,
were reported infrequently (ie, less than 1%) during domestic ulcerative
colitis and Crohn's disease trials. In many cases, the relationship to PENTASA
has not been established.

One week after completion of an 8-week ulcerative colitis
study, a 72-year-old male, with no previous history of pulmonary problems,
developed dyspnea. The patient was subsequently diagnosed with interstitial pulmonary fibrosis without eosinophilia by one physician and bronchiolitis
obliterans with organizing pneumonitis by a second physician. A causal
relationship between this event and mesalamine therapy has not been
established.

Postmarketing Reports

The following events have been identified during
post-approval use of the PENTASA brand of mesalamine in clinical practice.
Because they are reported voluntarily from a population of unknown size,
estimates of frequency cannot be made. These events have been chosen for
inclusion due to a combination of seriousness, frequency of reporting, or
potential causal connection to mesalamine:

Gastrointestinal: Reports of hepatotoxicity,
including elevated liver enzymes (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline
phosphatase, bilirubin), hepatitis, jaundice, cholestatic jaundice, cirrhosis,
and possible hepatocellular damage including liver necrosis and liver failure.
Some of these cases were fatal. One case of Kawasaki-like syndrome which
included hepatic function changes was also reported.